FDA.reportPublic FDA data

Amphetamine Extended-Release

Product NDC
62542-030
11-digit product format
625420030
Labeler code
62542
Product ID
62542-030_3f9283a3-e922-36ca-e063-6394a90a409d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine Extended-Release
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Neos Therapeutics, LP
Application
NDA204326
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-09-01
Substance
AMPHETAMINE
Active strength
18.8 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204326-001ADZENYS XR-ODTAMPHETAMINEEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD2016-01-27
N204326-002ADZENYS XR-ODTAMPHETAMINEEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD2016-01-27
N204326-003ADZENYS XR-ODTAMPHETAMINEEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD2016-01-27
N204326-004ADZENYS XR-ODTAMPHETAMINEEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD2016-01-27
N204326-005ADZENYS XR-ODTAMPHETAMINEEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD2016-01-27
N204326-006ADZENYS XR-ODTAMPHETAMINEEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD, RS2016-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N204326-001AB
N204326-002AB
N204326-003AB
N204326-004AB
N204326-005AB
N204326-006AB

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204326-00188409242026-04-09Drug product2016-02-26
N204326-00187094912032-06-28Drug product2016-02-26
N204326-00190177312032-06-28Drug product2016-02-26
N204326-00192657372032-06-28Drug product2016-02-26
N204326-00198396192032-06-28Drug product2024-04-22
N204326-00288409242026-04-09Drug product2016-02-26
N204326-00287094912032-06-28Drug product
N204326-00290177312032-06-28Drug product
N204326-00292657372032-06-28Drug product
N204326-00298396192032-06-28Drug product2024-04-22
N204326-00388409242026-04-09Drug product2016-02-26
N204326-00387094912032-06-28Drug product
N204326-00390177312032-06-28Drug product
N204326-00392657372032-06-28Drug product
N204326-00398396192032-06-28Drug product2024-04-22
N204326-00488409242026-04-09Drug product2016-02-26
N204326-00487094912032-06-28Drug product
N204326-00490177312032-06-28Drug product
N204326-00492657372032-06-28Drug product
N204326-00498396192032-06-28Drug product2024-04-22
N204326-00588409242026-04-09Drug product2016-02-26
N204326-00587094912032-06-28Drug product
N204326-00590177312032-06-28Drug product
N204326-00592657372032-06-28Drug product
N204326-00598396192032-06-28Drug product2024-04-22
N204326-00688409242026-04-09Drug product2016-02-26
N204326-00687094912032-06-28Drug product
N204326-00690177312032-06-28Drug product
N204326-00692657372032-06-28Drug product
N204326-00698396192032-06-28Drug product2024-04-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N204326-001ADZENYS XR-ODTEQ 3.1MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD2016-01-27a50c72e98297…
2026-08-01 22:54:322026-06N204326-002ADZENYS XR-ODTEQ 6.3MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD2016-01-27a50c72e98297…
2026-08-01 22:54:322026-06N204326-003ADZENYS XR-ODTEQ 9.4MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD2016-01-27a50c72e98297…
2026-08-01 22:54:322026-06N204326-004ADZENYS XR-ODTEQ 12.5MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD2016-01-27a50c72e98297…
2026-08-01 22:54:322026-06N204326-005ADZENYS XR-ODTEQ 15.7MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD2016-01-27a50c72e98297…
2026-08-01 22:54:322026-06N204326-006ADZENYS XR-ODTEQ 18.8MG BASETABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORALABRLD, RS2016-01-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N204326-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N204326-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N204326-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N204326-004AB1a50c72e98297…
2026-08-01 22:54:322026-06N204326-005AB1a50c72e98297…
2026-08-01 22:54:322026-06N204326-006AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N204326-00188409242026-04-09Drug product2016-02-26a50c72e98297…
2026-08-01 22:54:322026-06N204326-00187094912032-06-28Drug product2016-02-26a50c72e98297…
2026-08-01 22:54:322026-06N204326-00190177312032-06-28Drug product2016-02-26a50c72e98297…
2026-08-01 22:54:322026-06N204326-00192657372032-06-28Drug product2016-02-26a50c72e98297…
2026-08-01 22:54:322026-06N204326-00198396192032-06-28Drug product2024-04-22a50c72e98297…
2026-08-01 22:54:322026-06N204326-00288409242026-04-09Drug product2016-02-26a50c72e98297…
2026-08-01 22:54:322026-06N204326-00287094912032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00290177312032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00292657372032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00298396192032-06-28Drug product2024-04-22a50c72e98297…
2026-08-01 22:54:322026-06N204326-00388409242026-04-09Drug product2016-02-26a50c72e98297…
2026-08-01 22:54:322026-06N204326-00387094912032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00390177312032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00392657372032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00398396192032-06-28Drug product2024-04-22a50c72e98297…
2026-08-01 22:54:322026-06N204326-00488409242026-04-09Drug product2016-02-26a50c72e98297…
2026-08-01 22:54:322026-06N204326-00487094912032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00490177312032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00492657372032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00498396192032-06-28Drug product2024-04-22a50c72e98297…
2026-08-01 22:54:322026-06N204326-00588409242026-04-09Drug product2016-02-26a50c72e98297…
2026-08-01 22:54:322026-06N204326-00587094912032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00590177312032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00592657372032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00598396192032-06-28Drug product2024-04-22a50c72e98297…
2026-08-01 22:54:322026-06N204326-00688409242026-04-09Drug product2016-02-26a50c72e98297…
2026-08-01 22:54:322026-06N204326-00687094912032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00690177312032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00692657372032-06-28Drug producta50c72e98297…
2026-08-01 22:54:322026-06N204326-00698396192032-06-28Drug product2024-04-22a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adzenys XR-ODTAMPHETAMINENeos Therapeutics Brands, LLCc1179269-00b5-48ea-972d-31e614e99b7e2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 204326
application number: NDA204326
Amphetamine Extended-ReleaseAMPHETAMINE EXTENDED-RELEASENeos Therapeutics, LP48d0f55c-f847-4d26-b2ed-94b5a27702282025-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 204326
application number: NDA204326
ndc (product): 62542-030

Additional Listing Data#

Finished product
Yes
Brand name base
Amphetamine Extended-Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE18.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CK833KGX7EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1739803Internal RxNorm lookup
1739813Internal RxNorm lookup
1739819Internal RxNorm lookup
1739825Internal RxNorm lookup
1739831Internal RxNorm lookup
1739837Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48d0f55c-f847-4d26-b2ed-94b5a2770228Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
8b92ab59-8b26-4c89-a2d6-8d5140526ec6Product name320231213
4496d022-9224-4ee0-943a-50fbe6cd7123Product name220220901
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
93730fbf-8b45-4623-b27d-cf03825d04b3Product name520220314
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62542-030-30Amphetamine Extended-Release6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING65
62542-030-30Amphetamine Extended-Release30 in 1 CARTONTABLET, ORALLY DISINTEGRATING305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62542-030-30EA - Each62542-0308e33063f-009c-49d3-bf47-67f92da71da812025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739803amphetamine 12.5 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
1739813amphetamine 15.7 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
1739819amphetamine 18.8 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
1739825amphetamine 3.1 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
1739831amphetamine 6.3 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
1739837amphetamine 9.4 MG 24HR Extended Release Distintegrating Oral TabletPSN48d0f55c-f847-4d26-b2ed-94b5a27702285
173980324 HR amphetamine 12.5 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
173981324 HR amphetamine 15.7 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
173981924 HR amphetamine 18.8 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
173982524 HR amphetamine 3.1 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
173983124 HR amphetamine 6.3 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
173983724 HR amphetamine 9.4 MG Extended Release Oral TabletSCD48d0f55c-f847-4d26-b2ed-94b5a27702285
1739803amphetamine 12.5 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285
1739813amphetamine 15.7 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285
1739819amphetamine 18.8 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285
1739825amphetamine 3.1 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285
1739831amphetamine 6.3 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285
1739837amphetamine 9.4 MG 24 HR Extended Release Distintegrating Oral TabletSY48d0f55c-f847-4d26-b2ed-94b5a27702285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62542-030-306254200303030 BLISTER PACK in 1 CARTON (62542-030-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK30 blister pack2025-09-01NoNoCurrent